Functional uterine manipulator

ABSTRACT

A uterine manipulator can include a shaft including a first end, a second end, and a channel along an axis of the shaft, a handle coupled to the first end of the shaft, and a triangular balloon coupled to the second end of the shaft. The triangular balloon can be configured to inflate upon insertion into a vagina via a fluid injected into the channel of the shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/463,743, filed Mar. 20, 2017, which in turn is a continuation of U.S.application Ser. No. 14/463,798, filed Aug. 20, 2014, which is acontinuation-in-part of U.S. application Ser. No. 14/375,200, filed Jul.29, 2014, which is the National Stage of International Application No.PCT/US2012/065584, filed Nov. 16, 2012, which claims the benefit of U.S.Provisional Application No. 61/592,125, filed Jan. 30, 2012, thedisclosures of which are hereby incorporated by reference in theirentirety for all purposes.

BACKGROUND

The present disclosure relates generally to uterine manipulators andmethods of using a uterine manipulator for detaching the uterus andcervix from the vagina.

Uterine manipulators are conventionally used as aids in laparoscopichysterectomies to mobilize and position the uterus, to provide bettervisualization of the vagina and the cervix for facilitating theirseparation, and to remove the uterus after colpotomy is performed. Basicuterine manipulators include a handle, a shaft, an inflatable balloon,and a cervical stop. The handle is located at one side of the shaft andthe inflatable balloon is located near the tip of the other side of theshaft. The inflatable balloon is maneuvered into the uterus in andeflated condition and then inflated (e.g., via saline or water injectedthrough the shaft) to help stabilize the uterine manipulator during theprocedure and also to help remove the uterus after is has been separatedfrom the vagina. Once the uterine manipulator is positioned, thecervical stop can be adjusted to abut the cervix.

More complex uterine manipulators include a handle, a shaft, aninflatable balloon, a cervical cup, and an occluder. The handle, theshaft, and the inflatable balloon can have similar functions asdescribed above. The cervical cup can be fitted around the cervix andpressed inward against the vaginal fornix in order to provide anobservable or palpable landmark of the incision point for dissecting thecervix and uterus from the vagina and to physically separate theincision area from the nearby ureters. Using such complex uterinemanipulators, the incision for detaching the uterus and cervix from thevagina is executed laparoscopically (e.g., via a hook electrode). Theoccluder, positioned within the vagina when the uterine manipulator isset, makes continuous radial contact with the vaginal wall in order tomaintain pneumoperitoneum after the incision between the vagina and thecervix has been made. The occluder may be a silicone cup pushed up theshaft and pressed into the vagina, or a balloon slid onto the shaft andinflated so that it presses against the vaginal wall.

Current uterine manipulators can present drawbacks in certainsituations. For example, cup or balloon type occluders are in directcontact with the shaft and slid along the shaft for placement within thevagina. In some cases, this can inhibit rotation of the shaft whenattempting to manipulate the position of the uterus, for example to makeincisions around the fornix. In other cases, attempting to rotate theshaft can cause the occluder to slide along the shaft and disengage fromthe vaginal wall, resulting in a loss of pneumoperitoneum. In addition,current uterine manipulators only serve to provide guidance fordetaching the uterus and the cervix from the vagina via laparoscopictools.

Therefore, it would be desirable to have a uterine manipulator thatovercomes these drawbacks.

SUMMARY

The present disclosure provides a uterine manipulator that is operableto detach the uterus and cervix from the vagina. The uterine manipulatorcan include an umbrella-like tip that creates a secure connectionbetween the uterine manipulator and the uterus and cervix. The uterinemanipulator can also include a pneumooccluder that permits rotation ofthe manipulator shaft while maintaining pneumoperitoneum. The uterinemanipulator can further include a cutter that travels in a circle at thejunction of the cervix and the vagina, permitting detachment of theuterus and cervix from the top of the vagina.

In accordance with one aspect of the disclosure, a uterine manipulatoris provided. The uterine manipulator can be adapted for insertion into auterus for stabilizing and repositioning the uterus during ahysterectomy, where the uterus and cervix are detached from the vagina.The uterine manipulator can include a shaft, a handle, a tip assembly,and a cutting assembly. The shaft can include a first end and a secondend, and the handle can be coupled to the first end and be pivotablerelative to the first end about a first axis. The tip assembly can becoupled to the second end and pivotable relative to the second end alonga second axis parallel to the first axis, and can be adapted forinsertion into the uterus. The cutting assembly can be coupled aroundthe shaft and adapted to receive the cervix when the tip assembly isinserted into the uterus.

The foregoing and other advantages of the disclosed embodiments willappear from the following description. In the description, reference ismade to the accompanying drawings which form a part hereof, and in whichthere is shown by way of illustration a preferred embodiment of thedisclosure. Such embodiment does not necessarily represent the fullscope of the invention, however, and reference is made therefore to theclaims and herein for interpreting the scope of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a uterine manipulator according to thepresent disclosure.

FIG. 2 is another perspective view of the uterine manipulator of FIG. 1.

FIG. 3 is an exploded perspective view of the uterine manipulator ofFIG. 1 .

FIGS. 4A and 4B are partial side views of a handle and a tip assembly,respectively, of the uterine manipulator of FIG. 1 .

FIGS. 5A and 5B are additional partial side views of the handle and thetip assembly, respectively, of the uterine manipulator of FIG. 1 .

FIGS. 6A-6C are side views of the uterine manipulator of FIG. 1 indifferent pivoting positions.

FIGS. 7A-7D are side and front views of the handle assembly of theuterine manipulator of FIG. 1 in different pivoting positions.

FIGS. 8A and 8B are side views of the uterine manipulator of FIG. 1 in aretracted position and an expanded position, respectively.

FIGS. 9A and 9B are perspective views of a cutting assembly and abackstop, respectively, of the uterine manipulator of FIG. 1 .

FIGS. 10A and 10B are side views of the cutting assembly and anelectrical connector assembly, respectively, of the uterine manipulatorof FIG. 1 .

FIG. 11 is a perspective view of a pneumooccluder of the uterinemanipulator of FIG. 1 .

FIGS. 12A-12D are cross-sectional views of a pelvic cavity and theuterine manipulator of FIG. 1 .

FIG. 13 is a perspective view of a manipulator, cup, and cuttingassembly in accordance with the present disclosure.

FIG. 14 is a series of views showing use of the cutting assembly of FIG.13 in accordance with the present disclosure.

FIGS. 15A-15B are side views of a uterine manipulator in accordance withthe present disclosure.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate a uterine manipulator according to the presentdisclosure. At least one embodiment can be used in laparoscopichysterectomies, laparoscopic myomectomies, and/or other pelvicprocedures. The uterine manipulator 10 can include a handle 12, a shaft14, a tip assembly 16, a cutting assembly 18, a pneumooccluder 20, andan electrical connector assembly 22. During use, the uterine manipulator10 can be inserted into a patient's vagina no, as shown in FIG. 12A, andthen guided past the cervix 112 and into the uterus 114, as shown inFIG. 12B, using the handle 12. As shown in FIGS. 12B and 12C, when theuterine manipulator 10 is inserted, the tip assembly 16 can bepositioned in the uterus 114, the cutting assembly 18 can be positionedadjacent to the vaginal fornix 118 and can press against the cervix 112,and the pneumooccluder 20 can be positioned inside the vagina no.

As shown in FIG. 3 , the tip assembly 16 can include an expansion tip24, a tip shaft 26, expansion elements 28, an abutment 30, and a tiphousing 32, and the handle 12 can include a handle housing 34, anexpansion actuator 36, a cap 38, a hinge 40, hinge pins 42, and apivoting element 44. The shaft 14 can be coupled to the tip assembly 16via the tip housing 32, and can be coupled to the handle 12 via thepivoting element 44. The tip assembly 16 can be coupled to the handle 12via connectors 46. As shown in FIGS. 4A and 4B, the connectors 46 can berouted from inside the handle housing 34, through the shaft 14, andcoupled to the tip housing 32. As shown in FIGS. 3, 5A and 5B, expansionconnectors can be coupled to the expansion actuator 36, routed frominside the handle housing 34 through the shaft 14 and coupled to theexpansion tip 24 for actuating the tip assembly 16, as further describedbelow. In at least one embodiment, some or all of the components of theuterine manipulator 10 can be disposable. Some or all of the componentscan be removable from one another, for example, so that disposablecomponents can be uncoupled from permanent components and replaced withnew disposable components.

As shown in FIGS. 6A-6C, the tip assembly 16, the shaft 14, and thehandle 12 can be pivotable relative to each other at two separate pivotpoints 50, 52. The first pivot point 50 and the second pivot point 52can facilitate insertion of the uterine manipulator 10 into the uterus114 and can also facilitate repositioning of the uterus 114 during ahysterectomy. The first pivot point 50 can be located at the connectionbetween the tip housing 32 and the shaft 14. For example, as shown inFIGS. 4B and 5B, the end 54 of the tip housing 32 can be positionedbetween end components 56 of the shaft 14 so that through holes 58 ineach component 54, 56 are aligned, and a pin 60 can be routed throughthe through holes 58 to permit a pivotable connection. The second pivotpoint 52 can be located at the connection between the shaft 14 and thehandle 12. For example, as shown in FIGS. 4A, 5A, and 7A-7D, the shaft14 can be fixed to the pivoting element 44 (e.g., via a pin 60 andthrough hole 58 connection) and the pivoting element 44 can be pivotableabout the hinge 40 within the handle housing 34. The hinge pins 42 canextend through the handle housing 34, the hinge 40, and a track 62 ofthe pivoting element 44, as best shown in FIG. 7D. The track 62 can beribbed so that the pivoting element 44 cannot freely slide within it.Rather, the pivoting element 44 can be substantially fixed at specificpoints along the ribbed track 62 and only adjusted by applying an amountof force. This can prevent unwanted movement of the second pivot point52 unless a deliberate force is applied.

In at least one embodiment, an additional mechanism (for example, in thehandle 12), can be used to control both pivot points 50, 52. Forexample, if the additional mechanism is actuated in a first direction,both pivot points 50, 52 can be locked in place. If the additionalmechanism is actuated in a second direction, both pivot points 50, 52can be unlocked and maneuverable. The shaft 14 can be constructed of anon-rigid, flexible material to facilitate insertion of the uterinemanipulator 10 into the uterus 114.

The tip assembly 16 can act as an umbrella-like expansion componentcapable of being adjusted between a retracted position and an expandedposition. As a result, the tip assembly 16 can replace conventionalintra-uterine balloon elements. The tip assembly 16 can be situated intothe retracted position, as shown in FIGS. 8A and 12B, to facilitateinsertion into the uterus 114 (e.g., until the abutment 30 reaches thecervix 112). Once inserted into the uterus 114, the tip assembly 16 canbe deployed into the expanded position, as shown in FIGS. 8B and 12C, tofacilitate a secure connection between the uterine manipulator 10 andthe uterus 114 and cervix 112.

The expansion elements 28 can be spring-like elements capable of beingin compression (e.g., shortened in length) and in tension (e.g.,lengthened). Pulling the expansion actuator 36 away from the handlehousing 34 can cause the expansion elements 28 to compress and expandoutward circumferentially, situating the tip assembly 16 into theexpanded position. Pushing the expansion actuator 36 back into thehandle housing 34 causes the expansion elements 28 to retract back intotension and lengthen, situating the tip assembly 16 into the retractedposition. Alternatively, the expansion actuator 36 can be twisted orrotated, rather than pulled and pushed from the handle housing 34, toadjust the expansion elements 28.

As shown in FIGS. 4B and 5B, the expansion tip 24 can slide into the tipshaft 26 until an end stop 64 of the expansion tip 24 reaches the end 66of the tip shaft 26. The expansion elements 28 can fit over the tipshaft 26 until a first end 68 of the expansion elements 28 reaches theend 66 of the tip shaft 26. Both the expansion tip 24 and the tip shaft26 can be slid into the tip housing 32, while the second end 70 of theexpansion elements 28 can rest against an outer edge 72 of the tiphousing 32. Pulling the expansion actuator 36 outward from the handlehousing 34 causes the expansion connectors 48 to pull the expansion tip24, and the tip shaft 26, further into the tip housing 32. Because theexpansion elements 28 rest against the edge 72 of the tip housing 32,they are compressed (i.e., shortened in length) when the expansion tip24 and the tip shaft 26 are forced into the tip housing 32. Shorteningof the expansion elements 28 causes them to expand in theircircumferential direction, therefore situating the tip assembly 16 intothe expanded position. In the reverse, pressing the expansion actuator36 back into the housing releases the pulling tension of the expansionconnectors 48 on the expansion tip 24. The expansion elements 28 can bein a resting state when in tension and thus, without the pulling tensionby the expansion connectors 48, the expansion elements 28 will revertback to their resting, retracted state, thereby pulling the expansiontip 24 and the tip shaft 26 back out from the tip housing 32 andsituating the tip assembly 16 into the retracted position.

Referring back to FIGS. 1 and 2 , the cutting assembly 18 can be slidover the shaft 14 and can be rotatable about the shaft 14. The cuttingassembly 18 can include a backstop 74, a tube 76, a cutting handle 78,fasteners 80, and a spring 81. The backstop 74 can be positioned at afirst end of the tube 76 and the cutting handle 78 can be positioned ata second, opposite end of the tube 76. The tube 76 can be slid over theshaft 14 and the cutting handle 78 can help maneuver the cuttingassembly 18 along and/or around the shaft 14. The fasteners 80 can helpfix the cutting assembly 18 in place along the shaft 14. The backstop 74can receive the cervix 112 and come in contact with the vaginal fornix118 when the uterine manipulator 10 is in position. The backstop canthen be maneuvered in a circular manner to cut around the cervix 112 fordetaching the cervix 112 and the uterus 114 from the vagina 110, asshown in FIG. 12D. As shown in FIGS. 10A and 10B, the backstop 74 caninclude a round cup portion 82 and a cutter 84 extending outward fromthe cup portion 82. During use, the cutting assembly 18 can be pressedup against the abutment 30 of the tip assembly 16 so that the cupportion 82 extends past the abutment 30 and engages the fornix,stretching and forcing the fornix upward and away from the ureters. Thecutter 84 can pierce through the tissue of the fornix, transecting theuterus 114 and the cervix 112 from the top of the vagina 110.

The cutting assembly 18 can be rotated about the shaft 14 (e.g., by thecutting handle 78), allowing the cutter 84 to travel in a circle at thejunction of the cervix 112 and the vagina 110 and permitting completetransection of the uterus 114 and the cervix 112 from the vagina 110.The spring 81 can help distribute rotational forces evenly across thetube 76 when the cutting assembly 18 is rotated, for example, to preventthe tube 76 from breaking due to excess torque concentrated along oneportion of the tube 76.

The electrical connector assembly 22 can advance the cutter 84 outwardfrom the cup portion 82 to achieve the detachment procedure describedabove, and can retract the cutter 84 inward to facilitate insertion ofthe uterine manipulator 10 into the uterus 114 without piercing thevaginal walls 120 prior to proper positioning of the uterine manipulator10. The electrical connector assembly 22 can provide an electricalconnection between the cutter 84 and an electrosurgical unit (not shown)in order to provide hemostasis during the detachment procedure. Theelectrical connector assembly 22 can include a handle 94, a cap 96, abutton 98, tubing 100, 102, and electrical connectors 104, 106. On oneend of the electrical connector assembly 22 (i.e., adjacent to the cap96), the tubing 100 and the electrical connectors 104 can be routed tothe electrosurgical unit. On the other end of the electrical connectorassembly 22, the tubing 102 and the electrical connectors 106 can berouted to the cutter 84. The electrical connectors 104, 106 can beelectrically connected through the button 98 so that current can berouted from the electrosurgical unit to the cutter 84. The electricalconnectors 106 can be coupled to the cutter 84 and the button 98 so thatpressing the button 98 forward and backward causes the cutter 84 toextend and retract, respectively.

Referring to FIG. 11 , the pneumooccluder 20 can include a balloon 86, afilling tube 88, and a bearing 90. The bearing 90 can be in contact withthe tube 76 of the cutting assembly 18, and the balloon 86 can bepositioned around the bearing 90. As shown in FIG. 11 , the bearing 90can include an outer groove 92 to allow passage of the electricalconnector assembly tubing. During use, the pneumooccluder 20 can bepositioned within the vagina no when the uterine manipulator 10 is setwithin the uterus 114. Once in position, the balloon 86 can be inflatedvia the filling tube 88 (e.g., with air, water, saline, or anotherfluid) in order to seal the distal vaginal cavity 122 from the proximalvaginal cavity 124. This can help maintain pneumoperitoneum once theincision has been made between the vagina no and the cervix 112 (i.e.,causing the proximal vaginal cavity 124 to be in fluid communicationwith the abdominal cavity). As a result of the bearing 90, the shaft 14and/or the cutting assembly tube 76 can be rotated without requiringrotation of the balloon 86. Because the balloon 86 can be set in placeand does not need to be rotated when the shaft 14 or the cuttingassembly 18 is rotated, the risk of losing pneumoperitoneum is greatlyreduced.

Thus, the uterine manipulator 10 can be inserted into a patient's vagina110 while in the retracted position, as shown in FIG. 12A. The uterinemanipulator 10 can then be further guided through the vagina 110, pastthe cervix 112, and into the uterus 114, while still in the retractedposition, as shown in FIG. 12B. Once set in the uterus 114, the uterinemanipulator 10 can be situated into the expanded position, as shown inFIG. 12C, in order to facilitate a secure connection between the uterinemanipulator 10 and the uterus 114. Once the uterine manipulator 10 isset within the uterus 114, the pneumooccluder 20 can contact the vaginalwall 120 in order to seal the uterus 114 from the outside environmentand the backstop 74 can abut the vaginal fornix 118, causing it tostretch upward. Once the uterine manipulator 10 is situated into theexpanded position, the cutter 84 can be extended and the cutting handle78 can be rotated in order to transect the uterus 114 and the cervix 112from the top of the vagina no. The uterine manipulator 10 of the presentdisclosure and its above-described procedures can thus eliminate theneed for a colpotomy incision via laparoscopic tools, as in conventionallaparoscopic hysterectomies.

At least one embodiment can include any combination of one or more ofthe above-described components and/or other conventional uterinemanipulator components. The above-described components, such as thecutting assembly 18, the tip assembly 16, and the pneumooccluder 20 canfunction independently from one another and therefore can beindividually incorporated into a uterine manipulator with or without theother components. For example, it may be preferable to include thepneumooccluder 20 as described above with some previous approaches tobest execute a specific pelvic procedure.

Referring to FIG. 13 , a cutting assembly 200 is illustrated. Thecutting assembly 200 can be used with the functional uterine manipulator10 of the preceding figures or can be used with other systems. Thecutting assembly 200 includes a cup portion 202 and an expansion tip 204extending therethrough. As illustrated in FIG. 13 , the expansion tip204 can be a balloon-type design or other configurations, such asdescribed above. Associated with the cup portion 202 is a cutter orcutter wire 206. The cup portion 202 is designed to engage the cervix112, such as previously described. The cutter 206 is formed as a narrowwire, with a looped tip, embedded between two grooves 208, 210 on thecup portion 202 (that is, around the circumference of the cup portion202).

FIGS. 15A-15B illustrate another uterine manipulator 300. The uterinemanipulator 300 can include a handle 312, a shaft 314, a tip assembly316, and a cutting assembly 318. Unless otherwise stated, the elementsof the uterine manipulator 300 can be similar in function and structureto those of the above-described uterine manipulator 100 of the previousfigures. The uterine manipulator 300 can incorporate any of theabove-described elements of the previous figures. For example, the tipassembly 316 can include an expansion tip 324, a tip shaft 326,umbrella-like expansion elements 328, an abutment 330, and a tip housing332. The handle 312 can include a handle housing 334 and an expansionactuator 336. Twisting or rotating the expansion actuator 336 in a firstdirection causes the expansion elements 328 to compress and expandoutward circumferentially, situating the tip assembly 316 into theexpanded position. Twisting or rotating the expansion actuator 336 in asecond, opposite direction causes the expansion elements 328 to retractback into tension and lengthen, situating the tip assembly 316 into theretracted position.

The cutting assembly 318 can be rotatable about the shaft 314. Morespecifically, as shown in FIGS. 15A-15B, the uterine manipulator 300 caninclude a flexible shaft portion 315 along which the cutting assembly318 can slide laterally and/or rotated for proper positioning oroperation. The cutting assembly 318 can include a cup portion 382 and acutter or cutter wire 384. Similar to the cutter 206 of FIG. 13 , thecutter 384 can be formed as a narrow wire, with a looped tip 383,embedded between grooves (not shown) on the cup portion 382. Inaddition, the cup portion 382 can include a projection 385 to assist anoperator in locating the cutter 384 during an operation, to help shieldthe cutter 384 during insertion of the uterine manipulator 300, and/orto help push the cutter 384 through the vaginal tissue.

Referring to FIG. 14 , the cutter 206 (or the cutter 384) is preset in astored position 212 between the grooves 208, 210 (for example, when theuterine manipulator 100/300 is being inserted into a patient's uterus114). The cutter wire can be secured between the grooves 208, 210 bysmall, thin bridges (not shown) around the edge of the cup portion 202,with the looped tip of the cutter 206 extending outward from the grooves208, 210 at a 12 o'clock position. The bridges can be thin enough thatthey can be easily broken by pulling the cutter 206 against the bridgeswith sufficient force. The cutter 206 is designed to move from thestored position 212 to an extended position 214 where the cutter 206 canbe pushed through the top of the vagina (for example, with the help ofthe projection 383 of cup portion 382) after the cup portion 202 hasbeen positioned at a juncture between the cervix 112 and the vagina 110(for example, the vaginal fornix 118). In a further extended position216, the cutter 206 can be pulled in by a laparoscopic instrument 218,or “wand,” that is introduced laparoscopically. The instrument 218includes a trocar 220 that extends through the skin 222 to present ahandle 224 to a clinician. The instrument 218 also includes a smallgrasper 217 at its proximal end that can grasp or engage with the loopedtip of the cutter 206. Using the handle 224, the instrument 218 isdirected around the cup portion 202 and, as a result, pulls the cutter206 at position 226. As the cutter 206 makes contact with tissue at thejuncture of the vagina 110 and cervix 112, the tissue is cut, thusseparating the vagina 110 from the cervix 112 and uterus 114. At a finalposition 228, for example, once the cutter 206 has been pulled aroundthe circumference of the cup portion 202, the cutter 206 can beseparated from the cup portion 202. The laparoscopic instrument, withthe entire cutter 206, can then be removed through a laparoscopic portat the skin 222.

The inner groove 210 of the cup portion 202 can be taller than the outergroove 208 to prevent the cutter 206 from being pulled inward (insteadof upward or outward) as the instrument 218 pulls the cutter 206. Inaddition, the laparoscopic instrument 218 can include an outerinsulation cover 219 that is pushed forward while the cutter 206 ispulled out of the grooves 208, 210. That is, the cutter 206 is pulledinto or received in the laparoscopic instrument 218 so that the cutter206 is covered by the laparoscopic instrument 218 during operation,thereby enhancing safety given that the cutting wire or blade (which canbe carrying electrical current, as described below) is not exposed atany given time.

The cutter 206 can either cut the vagina without electrical current(“cold”) or with an electrical current, based on surgeon preference. Forexample, a distal end of the laparoscopic instrument 218 can connect toan electrosurgical unit (not shown) or electrical connector assembly,which can conduct monopolar or bipolar current. Accordingly, once thelaparoscopic instrument 218 grasps the cutter 206, current is passedthrough the instrument 218 and to the cutter wire 206. Differentoperations can be conducted based on monopolar or bipolarconfigurations. For example, in a monopolar configuration, the cutter206 can be pulled out of the cup portion 202 along its entirecircumference and removed via the laparoscopic instrument 218 (asdescribed above with reference to FIG. 14 ) while the cup portion 202remains fixed to a shaft (such as shaft 14 or 314). More specifically,the cup portion 202 is not rotated about the shaft during thisoperation. Power during monopolar operation can be relatively high, suchas about 100 watts.

In a bipolar configuration, the cutter 206 can be a shorter wire thanthe monopolar configuration, for example, about 2 centimeters (cm) toabout 3 cm. The cutter 206 can be pulled through the vaginal tissue bythe laparoscopic instrument 218, remaining at the 12 o'clock position,and then the cup portion 202 can be rotated about the shaft as thecutter 206 is held in place. One pole of the bipolar current can bethrough the laparoscopic instrument 218 (connected to the cutter wire206) and the other pole can be through the cup portion 202.

In at least one embodiment, the shorter cutter 206 can be held betweenthe grooves 208, 210 by a small ball (not shown) at a distal end of thecutter 206. The ball can help the cutter 206 slide around thecircumference of the cup portion 202 but also prevents the entire cutter206 from being pulled out from between the grooves 208, 210 as thelaparoscopic instrument 218 pulls the cutter 206. Once the cutter 206has traversed the entire circumference of the cup portion 202, a breakor opening (not shown) between the grooves 208, 210 can allow the ballto be pulled out from the cup portion 202 and into the laparoscopicinstrument 218 for removal. This ball configuration can be used withbipolar or monopolar applications. In bipolar applications, a smallmetal lining inside of the grooves 208, 210 can electrically connect thecup portion 202 to the ball (which is electrically connected to thelaparoscopic instrument 218).

The uterine manipulator 10, 300, 400, or at least one or more componentsof the uterine manipulator 10, 300, can be used with orifice-assistedsmall incision surgeries (OASIS). In such surgeries, instrumentation canbe inserted through a patient's belly button as well as the patient'svagina 110. The optical axis (e.g., of a laparoscope inserted throughthe belly button) can be decoupled from the operative axis (e.g., of asurgical tool inserted through the vagina 110). The uterine manipulator10, 300 can include an extension tool to assist with OASIS procedures.

The present disclosure has described one or more preferred embodiments.However, it should be appreciated that many equivalents, alternatives,variations, and modifications, aside from those expressly stated, arepossible and within the scope of the invention.

The invention claimed is:
 1. A uterine manipulator, comprising: a shaftincluding a proximal end, and a distal end; a manipulator handle coupledto the proximal end of the shaft; a cutting assembly rotatably disposedabout the shaft, the cutting assembly including: a tube rotatablydisposed about the shaft; a cutting handle coupled to a proximal portionof the tube; a cup to receive at least a portion of a fornix of apatient, the cup being coupled to a distal portion of the tube; and aretractable cutter extendable distally with respect to the cup, theretractable cutter being movable from a retracted position to anextended position, wherein the retractable cutter extends distallybeyond the cup when in the extended position, wherein the cuttingassembly can be rotated about the shaft by the cutting handle to allowthe retractable cutter to travel in a circle at a junction of a cervixand a vagina to permit transection of a uterus and a cervix from avagina; an outer tubular member surrounding the tube of the cuttingassembly to permit the cutting assembly to be rotated within the outertubular member while the outer tubular member is held stationary; apneumooccluder disposed on the outer tubular member, the pneumooccluderincluding an inflatable member coupled to a filling tube; an electricalconductor extending proximally from the retractable cutter at a locationthat is radially outward with respect to an exterior surface of the tubeof the cutting assembly and radially inward with respect to thepneumooccluder; a further tubular member extending along a length of themanipulator, the further tubular member being located radially outwardlywith respect to an exterior surface of the tube of the cutting assemblyand radially inward with respect to the pneumooccluder, wherein theelectrical conductor passes through a lumen defined at least in part bythe further tubular member; a mechanical actuator mechanically coupledto the retractable cutter, the mechanical actuator being operable tomechanically advance and retract the cutter between the extendedposition and retracted position; and an electrical connector toelectrically couple an electrosurgical unit to the retractable cutterthrough the electrical conductor.
 2. The uterine manipulator of claim 1,wherein the retractable cutter passes through a channel defined in thecup, and further wherein the retractable cutter slides with respect tothe channel defined in the cup when it is advanced and retracted.
 3. Theuterine manipulator of claim 1, wherein the retractable cutter includesa blade.
 4. The uterine manipulator of claim 1, further comprising adeployable anchor operably coupled to the distal end of the shaft, thedeployable anchor being configured for being expanded within a uterus.5. The uterine manipulator of claim 4, wherein the anchor includes atleast one surface that expands radially outwardly when deployed.
 6. Theuterine manipulator of claim 1, wherein the retractable cutter isconfigured to be electrified with electrical current.
 7. The uterinemanipulator of claim 6, wherein the retractable cutter is configured toapply electrical current in a bipolar configuration.
 8. Anelectrosurgical system, comprising the uterine manipulator of claim 7and an electrosurgical unit operably coupled to the retractable cutterof the uterine manipulator.